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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893709
Other study ID # FAMES
Secondary ID
Status Completed
Phase N/A
First received August 24, 2016
Last updated September 3, 2016
Start date June 2015
Est. completion date July 2016

Study information

Verified date September 2016
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to examine the effects of ethnicity, gender, and proton pump inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize that PPI therapy might perturb microbial communities and alter the gut microbiome. Young, healthy subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to provide a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and Day 14 (one week after stopping omeprazole). The DNA samples were subjected to 16S ribosomal ribonucleic acid (rRNA) sequencing.


Description:

Background and Aim: The objectives of this study are to examine the effects of ethnicity, gender, and proton pump inhibitor (PPI, omeprazole), on the human gut microbiome. PPIs are commonly used for the treatment of acid-related disorders. The investigators hypothesize that PPI therapy might perturb microbial communities and alter the gut microbiome.

Methods: Healthy subjects of Chinese (n=12), Malay (n=12) and Indian (n=10) ancestry, aged 21-37 years old, were enrolled. They were required to provide a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and Day 14 (one week after stopping omeprazole). Microbial DNA was extracted from the stool samples. This was followed by PCR, library construction, 16S rRNA sequencing using Illumina MiSEQ, and statistical and bioinformatics analyses.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 37 Years
Eligibility Inclusion Criteria:

1. Provision of signed written informed consent,

2. Aged between 21-35 years of age,

3. Chinese, Malay or Indian ancestry through three generations,

4. Clinical laboratory assessment results within normal limits, unless the deviation is considered not clinically significant by the investigator,

5. Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination, and results from clinical laboratory tests that are performed within 2 weeks before the baseline visit at Day 1,

6. Ability to communicate with the investigator and to understand and comply with all requirements of study participation.

7. Female subjects must be in the first half of their menstrual cycle (i.e. 1 to 14 days after the end of the previous menstruation) at Research Study entry.

Exclusion Criteria:

1. Any acute illness within 2 weeks before Day 1, unless otherwise approved by the PI,

2. Presence of chronic illnesses e.g. diabetes, renal disease, gastrointestinal disease, etc., which, in the opinion of the investigator, could compromise the data of the study,

3. Subjects who declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),

4. Treatment within the previous 3 months with antibiotics,

5. Treatment with any prescription or over-the-counter (OTC) medications, or herbal supplements within 4 weeks of Day 1 unless approved by the PI,

6. Consumption of probiotics or lactobacillus-containing products e.g. Yakult, Vitagen or Yogurt within 4 weeks of Day 1 unless approved by the PI,

7. Abnormal biochemistry indicators,

8. Poor peripheral venous access,

9. Involvement in the planning or conduct of this study,

10. Irregular bowel habits or complains of constipation problem.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
Omeprazole
Oral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days

Locations

Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (3)

Lead Sponsor Collaborator
Changi General Hospital National University, Singapore, Universiti Teknologi Mara

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Clooney AG, Bernstein CN, Leslie WD, Vagianos K, Sargent M, Laserna-Mendieta EJ, Claesson MJ, Targownik LE. A comparison of the gut microbiome between long-term users and non-users of proton pump inhibitors. Aliment Pharmacol Ther. 2016 May;43(9):974-84. doi: 10.1111/apt.13568. Epub 2016 Feb 29. — View Citation

Freedberg DE, Toussaint NC, Chen SP, Ratner AJ, Whittier S, Wang TC, Wang HH, Abrams JA. Proton Pump Inhibitors Alter Specific Taxa in the Human Gastrointestinal Microbiome: A Crossover Trial. Gastroenterology. 2015 Oct;149(4):883-5.e9. doi: 10.1053/j.gastro.2015.06.043. Epub 2015 Jul 9. — View Citation

Imhann F, Bonder MJ, Vich Vila A, Fu J, Mujagic Z, Vork L, Tigchelaar EF, Jankipersadsing SA, Cenit MC, Harmsen HJ, Dijkstra G, Franke L, Xavier RJ, Jonkers D, Wijmenga C, Weersma RK, Zhernakova A. Proton pump inhibitors affect the gut microbiome. Gut. 2016 May;65(5):740-8. doi: 10.1136/gutjnl-2015-310376. Epub 2015 Dec 9. — View Citation

Jackson MA, Goodrich JK, Maxan ME, Freedberg DE, Abrams JA, Poole AC, Sutter JL, Welter D, Ley RE, Bell JT, Spector TD, Steves CJ. Proton pump inhibitors alter the composition of the gut microbiota. Gut. 2016 May;65(5):749-56. doi: 10.1136/gutjnl-2015-310861. Epub 2015 Dec 30. Erratum in: Nat Rev Gastroenterol Hepatol. 2016 Apr;13(4):188. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in species diversity after omeprazole treatment, as measured by diversity indices 1 week, 2 weeks No
Primary Emergence of signature taxa after omeprazole treatment, as measured by indicator value 1 week, 2 weeks No
Primary Differences in species diversity between gender, as measured by diversity indices Baseline No
Primary Differences signature taxa among ethnic groups, as measured by indicator value Baseline No
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